Identity
- Trade Name
- Kinos Axiom FDA UDI
- Generic Name
- Ankle prosthesis bearing FDA UDI
- Device Name
- Anatomic Bearing Implant Size 3, Right, 12mm FDA UDI
- Model / Reference
- 3801-2312 FDA UDI
- Description
- Anatomic Bearing Implant Size 3, Right, 12mm FDA UDI
Identifiers
- Catalog Number
- 3801-2312 FDA UDI
- Primary DI / UDI-DI
- 00850022178498 FDA UDI
- 510(k) Number
- K192778 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Ankle prosthesis bearing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ankle prosthesis bearing
Kinos Axiom by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ankle prosthesis bearing.
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- Hintermann Series H2 — Dt Medtech, LLC · Class II
- Hintermann Series H2 — Dt Medtech, LLC · Class II
- Hintermann Series H2 — Vilex, Inc. · Class II
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class II
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class II
- Hintermann Series H2 — Vilex, Inc. · Class II
Cleared under the same submission
K192778 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Restor3D
Sources (1)
- FDA UDI 0607f187-941f-4d89-8dd7-9c5e1b2f9ee7 35 fields · synced May 30, 2026